The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-05-26
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Those who are 19 years of age or older and 55 years of age

• BMI 18.5 ~ 27.5 kg/m2

• Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial

Exclusion Criteria:

• Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.

• Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs

• Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days

• Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug

• Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range

• Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test

• In the case of women, those who do not show a negative response on the pregnancy test

• Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests